Clinical trials support office is a new trend

Institution plans call for increasing research

One way an institution can promote research and provide support to clinical trials coordinators and investigators is through the formation of a clinical trials support office.

Thomas Jefferson University of Philadelphia has recently formed a clinical trials support office as part of the university’s strategic plan for expanding clinical trials, says Roseann Talarico, associate director of the clinical trials office at the university.

"What I’m working on is a mission and goals and part of it is supporting faculty members who are doing clinical research by providing a variety of administrative and clinical support services," she says.

One of the goals is to expedite the contractual process from the beginning when the principal investigator receives the protocol from the sponsor, says Ronald Polizzi, associate director of contracts at Thomas Jefferson University.

"It’s done manually now," he says. "Our goal is to put a strong system in place that should speed up the process, make it simpler."

Ideally, once the support system is fully under way, principal investigators will have the information and assistance they need to feel comfortable pursuing new research contracts, Polizzi says.

"Principal investigators will be much more aggressive in reviewing contracts and protocols and say, I want to do this study,’ instead of being hindered by roadblocks and delays," Polizzi says.

The process of forming the support office is about halfway developed, but its formation may provide a blueprint for administrators with other research institutions.

The blueprint includes these features:

— regulatory compliance training;
— business aspects of a clinical trial;
— documentation during a clinical trial process;
— role of the grants manager in clinical trials;
— flowchart for pre-award process;
— streamlined clinical trial process;
— pool of study coordinators;
— web site with internal and external links.

Polizzi and Talarico offer these ideas for what a clinical trials support office could do for an institution and its research staff:

Develop database of investigator interests: "We’re working on developing a database of principal investigators’ interests and a database of the patient population by disease," Talarico says. "That information is not located in one central location."

The goal is to coordinate the information in such a way that as the university aggressively seeks to expand its research contracts it will be easy to match an investigator with a patient population, she says.

Form task force: Thomas Jefferson University has a task force with four subcommittees, including a hospital, fiscal review, university, and Jefferson University physicians, Talarico says.

"The No. 1 issue is standardizing costs," she says.

The idea is to have an on-line description of the support office’s services so fiscal managers can have the information readily available as they’re preparing budgets, Talarico says.

"We’re working closely with hospital representation on formulating a policy for fiscal review committee so we can delineate the expenses up front in a protocol and separate the standard of care vs. research expenses — so it’s not a gray area after the fact," she explains.

Coordinate training/education: When the Thomas Jefferson University clinical trials office is fully developed, one goal is to provide investigators, IRB members, and research staff with an idea of what training courses are available in every department, Talarico says.

"We’ll have an on-line service so individual business managers can go in and see if key personnel have taken the training necessary to be on a clinical trial," she says. "We’re working in collaboration with the IRB to establish more educational programs for clinical faculty members and chairs."

Improve contract review process: Principal investigators have expressed an interest in improving the contract review and negotiation process, Polizzi notes.

"We’re trying to speed up the process," he says. "We want to have everything float smoothly from program to program with all processes in place, including the IRB, the clinical trials coordinator, the hospital — so they’ll all have access to the same system."

To meet that goal, Polizzi and Talarico are meeting with hospital departments, learning each department’s system, pricing, and management styles, Polizzi says. "We’re trying to get everyone on the same page."

For example, contract language often is an issue as each department might use its own. "One answer is that we could coordinate between departments, he says.

This way, the informed consent language would match the contract language regarding patient identification and other items, Polizzi explains. "Sometimes the IRB or clinical trials coordinator is looking at it one way, and I’m looking at it another way, and that causes a delay, That’s a problem where the departments need to communicate with each other, and if we had an on-line system, we could do that by logging on."

The way it works currently is that everything is on paper and everyone involved works in different buildings, he adds.

"We meet with coordinators monthly, and we’re trying to break communication barriers so they can ask us what they need," Polizzi says.

The objective is to create a standardized contract template that could be used with industry sponsors, he notes.

"If we had a boilerplate to use with the same sponsor, all we’d have to do is change the statement of work because the master agreement would already be in place," Polizzi says. "We’ve already had six boilerplates with certain sponsors, and these will expedite contract negotiation."

Too often contract negotiations are hung up on the issues of publication and intellectual property, but with a boilerplate already negotiated, the hope is that these issues would already be resolved, he explains.

This would streamline the process, making it move along more quickly, and sponsors are receptive to the idea because it also saves them time and money, Polizzi adds.

Make the support office a one-stop shop: "The goal is to support our faculty members so they can come to this clinical trials office for any aspect of the clinical trials process and we can coordinate all these processes for them," Talarico says.

"We also want to be able to make a type of business development office, another component where we can match up our investigators with industry," she adds. "We’d have a database of industry sponsors and principal investigators and hopefully that will increase our clinical trial activity."

The university already provides support for grant writing through its faculty development program, and Talarico’s office is located with the office of research administration, so these support services work well together.

Create network for research professionals: The Jefferson Clinical Research Forum was developed to create a network for research professionals and a mentoring system.

"We found there is a lack of coordinators," Talarico says. "Principal investigators could be watching two or three trials at one time and could do another two, but don’t have the study coordinators or resources to hire them."

So the goal is to develop a pool of coordinators who could be loaned out to investigators, she says.

During interviews with principal investigators a recurring theme was they could take on another clinical trial if they had assistance, but the available coordinators were spread too thin, Talarico adds.

"If we could provide coordinators on a regular basis, this could increase their trial activity," she adds. "The issue is we’re in a very competitive area with five major schools and a lot of pharmaceutical companies, and we find a lot of our turnover is to pharmaceutical companies."

Another goal is to provide more consistency in the training of coordinators, who typically come from a wide variety of backgrounds, including previous experience as clinical nurses, secretaries to investigators, etc., Polizzi notes.

"Say you have someone who became a nurse and decided to get into research," he notes. "That person may have a lot of knowledge about nursing, but not as much in research, so there’s a lot of turnover and change among coordinators."

The institution’s IRB provides a two-day coordinator session on the history of the IRB, and there are certification courses available, but more training is needed, Talarico says.

Provide pre-award proposal assistance: One of the essential functions for the clinical trials office will be the day-to-day activity for pre-award proposal assistance, Talarico says.

"We provide guidance and coordination of the Office of Research Administration and the Office of Scientific Affairs and Activities, including the IRB and human subjects protection," she reports. "We want to assist them with internal forms and the budget preparation process with the sponsor and creating a budget template."

The goal is to identify problem areas for the principal investigator in a timely fashion to facilitate the placement of trials, Talarico says.

"We’re looking at the feasibility of studies for our patient populations," she says. "We want to stay competitive, standardize costs, and create a central repository for all sponsors."

The support office staff will meet with principal investigators to find out what their relationships are with sponsors and to expand the repository, Talarico adds.

"We want to build a portfolio with specialties like therapeutic areas to match principal investigators and sponsors requirements in a timely fashion," she explains. "We would like to develop a marketing tool to develop outreach sessions to the community and pharmaceutical and medical device companies."

Once the clinical trials office is fully established, another goal is to have a toll-free number for the clinical trials, so members of the public can call to find out how they might become research subjects, Talarico adds.